141
Participants
Start Date
April 30, 2003
Primary Completion Date
March 31, 2009
Study Completion Date
March 31, 2009
AP 12009 10 µM
10 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks
AP 12009 80 µM
80 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks
temozolomide or PCV
temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen
Drug delivery system for administration of AP 12009
Drug delivery system for Convection Enhanced Delivery consists of a portable pump with drug reservoir and infusion line. Main implanted parts are the port access system and the intratumoral catheter.
Placement of Drug Delivery System
Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
Kaiser Franz Josef Spital, Abteilung für Neurologie, Vienna
Landes-Nervenklinik Wagner-Jauregg, Linz
Universitätsklinik Innsbruck; Abteilung für Neurochirurgie, Innsbruck
Medizinische Klinik und Poliklinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Mitte, Berlin
Universitätsklinikum Kiel, Klinik für Neurochirurgie, Kiel
Rambam Medical Center, Neurosurgery Department, Haifa
Universitätsklinikum Gießen, Neurochirurgische Universitätsklinik, Giessen
Universitätsklinik Magdeburg, Klinik für Neurochirurgie, Magdeburg
Universitätsklinikum Münster, Klinik und Poliklinik für Neurochirurgie, Münster
Rabin Medical Center, Neurosurgery Department, Petah Tikva
Universitätskliniken Mainz, Neurochirurgische Klinik und Poliklinik, Mainz
Klinikum Saarbrücken, Neurochirurgie, Saarbrücken
Neurologische Universitätsklinik Tübingen, Tübingen
Klinikum und Poliklinik für Neurologie, Universität Regensburg, Regensburg
Department of Neurosurgery, Neurosciences Center, New Dehli
Burdenko Neurosurgery Research Institute, Moscow
Polenov Neurosurgery Research Institute, Saint Petersburg
Military Medical Academy named after I.S.M. Kirov, Neurosurgery Department, Saint Petersburg
"Medical Center XXI century", Saint Petersburg
Department of Neurosurgery, LTMG Hospital & LTM Medical College, Mumbai
Republican Clinical Hospital of Ministry of Health of Tatarstan Republic, Kazan'
State Institution of Healthcare, Samara Regional Clinical Hospital in the name of M.I. Kalinin, Samara
Tcheliabinsk Regional Clinical Hospital; State Medical Institution for Prophylaxis and Treatment, Chelyabinsk
Department of Medical Oncology, Nizam's Institute of Medical Sciences, Hyderabad
Manipal Hospital; Manipal Institute for Neurological Disorders, Bangalore
Department of Neurosurgery, National Institute of Mental Health and Neurosciences, Bangalore
Sverdlovsk Regional Oncological Clinic, Yekaterinburg
Department of Neurological Sciences, Christian Medical College & Hospital, Vellore
Omsk State Medical Academy; State Educational Institution of Higher Professional Education, Omsk
Department of Neurosurgery, Amrita Institute of Medical Sciences & Research Centre, Kochi
Sree Chitra Tirunal Institute for Medical Sciences & Technology, Department of Neurosurgery, Trivandrum
Sarajishvili Institute of Clinical Neurology and Neurosurgery, Tbilisi
Klinik und Poliklinik für Neurologie, Cottbus
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurochirurgie, Leipzig
Soroka Medical Center, Neurosurgery Department, Beersheba
Lead Sponsor
Isarna Therapeutics GmbH
INDUSTRY